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Qiagen Sciences LLC Recall 87205

Description: SARS-CoV-2 Antigen Test

Qiagen Sciences LLC Recall 87205 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0941-2021
Event ID87205
Event DescriptionSARS-CoV-2 Antigen Test
Product TypeDevices
DistributionDomestic: AZ, CA, DC, CO,FL,HI, IL, KY, MI, MO, NC, NJ, NM, NY, OH, RI, TX, WA, WY
Quantity1092 boxes of 60 (65,520 e-sticks)
Recall ReasonQIAGEN has become aware of the potential for false positive results to occur with some patient samples.
Device Classification20210210
Device Code InfoGTIN: 04053228039785, Catalog #: 646533, Lot #: 86651, 86652, 86653, 86654, 86659.
Center Classification Date20210131
Recall Initiation Date20210115
Recalling FirmQiagen Sciences LLC
Initial Notification Other
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